Tracheal tube

ABSTRACT

In an embodiment, a tracheal tube system has a first tube, which is flexible. The tube has an opening that is located on the sidewalls. A balloon is attached to the flexible tube. When inflated, the balloon forms a second tube surrounding the first tube with an air space between the first wall of the balloon and the sidewalls of the first tube. The balloon extends covering the opening on the sidewall. Air flowing into the first tube exits, via the third opening into the airspace between the first tube and the balloon, out of the airspace. In another embodiment, the balloon has a tube with multiplicity of holes in the walls is wrapped around the outer wall of the balloon. Negative pressure in the third tube creates suction holding the outer wall of the balloon to walls of the trachea.

FIELD

This specification generally relates to the field of tracheal tubes.

BACKGROUND

The subject matter discussed in the background section should not beassumed to be prior art merely as a result of its mention in thebackground section. Similarly, a problem and the understanding of thecauses of a problem mentioned in the background section or associatedwith the subject matter of the background section should not be assumedto have been previously recognized in the prior art. The subject matterin the background section may merely represents different approaches,which in and of themselves may also be inventions.

Tracheal tubes with inflatable balloon with suction means are broadlyknown in the prior art. However, the suctioning means of such prior artsare inefficient with suctioning secretions above and around the balloon,therefore allowing secretions and/or pathogens to travel through theballoon and tracheal walls and into the airflow of the tracheal tube. Incertain situations, the secretions/pathogens get aerosolized by the highvelocity of the ventilated air traveling through the tracheal tube andinto the patient's lungs. Aerosolized pathogens traveling at highvelocity may send the pathogens deep into the lungs which may causeVentillator Associated Pneumonia (VAP).

BRIEF DESCRIPTION OF THE FIGURES

In the following drawings like reference numbers are used to refer tolike elements. Although the following figures depict various examples ofthe invention, the invention is not limited to the examples depicted inthe figures.

FIG. 1 shows a diagram of an embodiment of a tracheal tube.

FIG. 2 shows a diagram similar to that of FIG. 1 but illustratinganother embodiment of a tracheal tube.

FIG. 3 shows a cross-sectional view of an embodiment of the catheter ofFIG. 1 taken longitudinally through the catheter along the 3-3 cut lineof FIG. 1.

FIG. 4 shows a cross-sectional view of an embodiment of a catheter and aballoon of FIG. 1 taken longitudinally through the catheter and theballoon along the 4-4 cut line of FIG. 1.

FIG. 5 shows a drawing of an embodiment of an assembly of a balloon.

FIG. 6a shows a flowchart of an embodiment of a method for inserting theendotracheal tube.

FIG. 6b shows a flowchart of an embodiment of a method for removing theendotracheal tube.

FIG. 7a shows a flowchart of an embodiment of a method for suctioningsecretion from the border of the cuff and trachea region.

FIG. 7b shows a flowchart of an embodiment of a method for rinsing fluiddispensing device is applying a rinsing fluid.

FIG. 7c shows a flowchart of an embodiment of a method for artificiallyventiliating a patient.

FIG. 8 shows a flowchart of an embodiment of a method manufacturing atracheal tube.

FIG. 9 shows a flowchart of an embodiment of a method for manufacturinga tracheal tube.

FIG. 10 shows a flowchart of an embodiment of a method for creating aballoon.

FIG. 11 shows a flowchart of an embodiment of a method for attaching aballoon to the endotracheal tube.

DETAILED DESCRIPTION

Although various embodiments of the invention may have been motivated byvarious deficiencies with the prior art, which may be discussed oralluded to in one or more places in the specification, the embodimentsof the invention do not necessarily address any of these deficiencies.In other words, different embodiments of the invention may addressdifferent deficiencies that may be discussed in the specification. Someembodiments may only partially address some deficiencies or just onedeficiency that may be discussed in the specification, and someembodiments may not address any of these deficiencies.

In general, at the beginning of the discussion of each of FIGS. 1-5 is abrief description of each element, which may have no more than the nameof each of the elements in the one of FIGS. 1-5 that is being discussed.After the brief description of each element, each element is furtherdiscussed in numerical order. In general, each of FIGS. 1-5 is discussedin numerical order and the elements within FIGS. 1-5 are also usuallydiscussed in numerical order to facilitate easily locating thediscussion of a particular element. Nonetheless, there is no onelocation where all of the information of any element of FIGS. 1-5 isnecessarily located. Unique information about any particular element orany other aspect of any of FIGS. 1-5 may be found in, or implied by, anypart of the specification.

FIG. 1 shows a diagram of an embodiment of a tracheal tube system 100.The tracheal tube system 100 may include at least one connector 102, acatheter 106 having opposed open proximal end 104 and open distal end122, a suction device 108 a, an air dispensor device 108 b, a fluiddispensor device 108 c, a fluid reservoir 108 d, at least one suctiontube 108 e, at least one inflation tube 110 a, a pilot balloon 110 b,inflation fluid supplying device 110 c, at least one suction tube lumen112, at least one inflation tube lumen 114, at least one suction lineexit 116, at least one balloon 118, at least one suction line 120, atleast one enlarged opening 124, and at least one enlarged air passageway 126. In other embodiments the tracheal tube system 100 may not haveall of the elements or features listed and/or may have other elements orfeatures instead of or in addition to those listed.

The tracheal tube system 100 is a tracheal tube with a 360 degreesuction line and an enlarged airflow passage. In an embodiment,suctioning is set at 15 mm Hg negative pressure. The tracheal tubesystem 100 may be adapted to be used for various tubes such asendotracheal, endobronchial, and tracheostomy tubes. The endotrachealtube 100 is a catheter that is inserted into the trachea through themouth or nose in order to maintain an open air passage or to deliveroxygen, medications, or to permit the suctioning of mucus or to preventaspiration of oral secretions. Endotracheal tube 100 may be a flexible,hollow cylindrical tube that is open at both ends to allow air to passthrough.

The connector 102 is a connection adapted to connect to a mechanicalventilator. The connector 102 attaches the tracheal tube system 100 to amechanical ventilator. In an embodiment, the connector 102 may have alength of 4 cm, a proximal Outer Diameter (OD) of 1.5 cm, a proximalInner Diameter (ID) of 1.3 cm, and a proximal length of 1.5 cm. the areaof the safety is 1.5 cm×2.5 cm. In an embodiment, the length of thesafety is 0.5 cm. In an embodiment, the distal opening OD of connector102 is 0.8 cm. In an embodiment, the distal length of connector 102 is 2cm. In an embodiment the tolerance for all of the listed dimensions inthis specification is +/−10% of the value of the dimension in question.In another embodiment the tolerances in this specification is +/−5% ofthe dimension in question. In an embodiment, the connector 102 is madefrom hard polypropylene. In other embodiments, the mechanical ventilatormay be replaced with an air bag if a mechanical ventilator is notavailable.

The proximal end 104 is the end of the tracheal tube system that is notintubated inside the patient. In this specification, to intubate apatient refers to placing a tube in the patient. For example,intubulating a patient may refer to the inserting a breathing tube intothe trachea for mechanical ventilation. The proximal end 104 is open andconnected to the end of the connector 102 opposite the mechanicalventilator. In an embodiment, the proximal end 104 has a length of 31cm. In an embodiment, the proximal end 104 is made from flexiblepolyvinylchloride.

The catheter 106 is a tube that is inserted into the body in order toaid delivery of medications. The catheter 106 may be inserted into thetrachea to deliver oxygen. The catheter 106 may be made from a tube. Thecatheter 106 may be made out of plastic (e.g., polyvinyl chloride, PVC).The plastic materials may be visually clear or opaque. Since plastic isnot radio opaque, the catheter 106 may have a line of radio opaquematerial that makes the tube more visible on a chest X-ray. In otherembodiments, the catheter 106 may be made out of wire-reinforcedsilicone rubbers. Yet in other embodiments, the catheter 106 may be madeout of silicone rubber, latex rubber, or stainless steel. The differentmaterials used to make a tracheal tube usually depends on theapplication of the tube that is required. For example, a wire-reinforcedsilicone rubber catheter is quite flexible yet difficult to compress orkink, making the wired-reinforced silicone rubber catheter useful forsituations in which the trachea is anticipated to remain intubated for aprolonged duration, or if the neck needs to remain flexible duringsurgery.

The catheter 106 have an inner diameter and an outer diameter. The“size” of a tracheal tube refers to the inner diameter of the catheter.For example, if someone asks for a “size 6” tracheal tube, they areasking for a tracheal tube with an inner diameter of 6 mm. Furthermore,the inner diameter may be labeled on the catheter 106 as “ID 6.0.”Narrower tubes increase the resistance to gas flow. For example, a size4 mm tube has sixteen times more resistance to gas flow than a size 8 mmtube. The additional resistance can be especially relevant in thespontaneously breathing patient who will have to work harder to overcomethe increased resistance. Therefore, when choosing the appropriate“size”, the largest size that is suitable for a given patient istypically recommended. For human beings, the size of the catheter 106may range from 2.0 mm for neonates to 10.5 mm for adult males. Thecatheter 106 may have an OD of 0.7 cm to 0.9 cm (depending on the sizeof the patient).

The catheter 106 may have varying lengths depending on who or what isusing the catheter 106. The length of the catheter 106 is measured fromthe end that goes into the trachea. The length of the catheter may varyif the catheter 106 is inserted orally or through the tracheostomystoma. For human beings with an oral insertion, the length of thecatheter 106 may range from 7.5 cm for neonates to 23 cm for adultmales. In an embodiment, the catheter 106 may be inserted orally ornasally as an endotracheal tube.

In another embodiment, the catheter 106 may be inserted into atracheostomy stoma and used in a tracheostomy. A tracheostomy is anopening through the neck into the trachea through which a tube may beinserted to maintain an effective airway and help a patient breathe. Atracheostomy stoma is the actual opening. When the catheter is used in atracheostomy, the length of the catheter 106 may be shorter.

The primary channel 107 is the main passageway of the catheter 106 fordelivering gases containing oxygen to a patient or for extracting carbondioxide (CO₂) from a patient. The OD of primary channel 107 is variablefrom 0.6 cm to 0.8 cm. In an embodiment, the diameter of the primarychannel 107 is the same as the inner diameter of catheter 106.

The suction device 108 a is a machine that can be used to remove mucousand other unwanted fluids from a patient. The suction device 108 acreates a negative pressure in order to extract mucous and otherunwanted fluids from a patient. The suction device 108 a may have avarying power of suction. The suction device 108 a may run continuouslyat a low power of suction setting to provide a constant suction. Thesuction device 108 a may run on an as needed basis, depending on thesituation of application.

The air dispensor device 108 b is a machine that can be used to pumpair. The air dispensor device 108 b may be an electronically powered airdispensor or a manual air pump such as a syringe filled with air.

The fluid dispensor device 108 c is a machine that is used to pumpfluid. The fluid dispensor device 108 c may be an electronically poweredfluid dispensor with varying or fixed power of dispensing. The fluiddispensor device 108 c may also be a manually operated device such as asyringe filled with a fluid.

The fluid reservoir 108 d is a reservoir for storing rinsing fluid todispense into a patient to help loosen mucous build up to allow for aneasier extraction. The fluid reservoir may be water to be used as acleaning agent and/or may include another cleaning agent, or may besaline or an antibiotic rinse. The fluid reservoir 108 d may be thefluid source for the fluid dispenser device 108 c. In some embodiments,fluid dispenser device 108 c may not need to draw from the fluidreservoir of 108 d.

The suction tube 108 e is a tube adapted to suction secretion collectedinside the border of the cuff and trachea region around the trachealtube. The border of the cuff and trachea region is the part of thecavity of the larynx below the true vocal chords. The suction tube 108 emay be adapted to connect to a suction device to suction the secretion.In some embodiments, the suction tube 108 e may be attached to thecatheter 106 proximal to the open proximal end 104. In otherembodiments, the suction tube 108 e may extend into the inner walls ofthe catheter 106. The suction tube 108 e length is 24 cm. The suctiontube 108 e may be made from flexible polyvinylchloride.

In another embodiment, the suction tube 108 e may be adapted to connectto an air dispensing device 108 b to dispense air into the suction tube108 e to clear out the suction tube.

In yet other embodiments, the suction tube 108 e may be adapted toconnect to a fluid dispensor device 108 c to provide a rinsing fluid.The fluid dispensor device may draw the rinsing fluid from the fluiddispensing reservoir 108 d. The purpose of the rinsing fluid may be toloosen up the secretion and mucous surrounding the border of the cuffand trachea region around the trachea to loosen mucous which may collectaround the tracheal tube. Once the rinsing fluid has been introduced,suction may be restored to the suction tube 108 e and the liquid and anysecretions that may have been loosened or dissolved may be removed. Theintroduction of a rinsing fluid procedure may be repeated as deemednecessary and it is performed at the discretion of the caregiver or userin order to clean secretions and other liquids that may collect andpotentially clog the suction. The rinsing fluid may comprise water,saline, as well as other biocompatible liquids or mucolytic agents. Amucolytic agent is an agent which dissolves thick mucus and is usuallyused to help relieve respiratory difficulties. It does so by dissolvingvarious chemical bonds within secretions, which in turn can lower theviscosity by altering the mucin-containing components.

The inflation tube 110 a is a tube used to supply an inflation fluid. Inan embodiment, the inflation tube 110 a length is 24 cm. In anembodiment, the inflation tube is made from flexible polyvinylchloride.

The pilot balloon 110 b is a balloon that provides an indication of theair pressure that exists in another balloon that it is connected to.Furthermore, the pilot balloon 110 b has a one way valve that preventsair inflated into the pilot balloon 110 b from deflating because of theone way valve design. The pilot balloon 110 b may serve as a balloondeflator when the pilot balloon 110 b is pressed, thus turning the oneway valve into a two way valve.

The inflation fluid supplying device 110 c is a device that delivers aninflation fluid. The inflation tube 110 a may be connected to theinflation fluid supply device 110 c by way of pilot balloon 110 b. Thefluid supplying device 110 c may be a syringe or a pump. The inflationfluid may be a gas or a liquid, depending on the desired functionalitiesof the inflation fluid. The inflation fluid may be air. The inflationfluid may also be a methylene blue coloured saline. For example, someairway surgery involves the use of laser beams to burn away tissue.These beams can ignite ordinary endotracheal tubes and in the presenceof Oxygen may cause major airway fires. If the laser manages to damagethe balloon, the coloring will help identify rupture and the saline willhelp prevent an airway faire.

The suction tube lumen 112 is an extension of the suction tube 108 ethat extends along the length of the catheter 106. The suction tubelumen 112 further provides suction to the tracheal tube from the suctiontube 108 e. The suction tube lumen 112 may be connected to the suctiontube 108 e or it may be an extension of suction tube 108 e that isconnected to the catheter 106. The suction tube lumen 112 may alsoextend along the length and inside the walls of catheter 106. In anotherembodiment, the suction tube lumen 112 may attach to the exteriorsurface of the catheter 106 and extend along the length of the catheter106. In other embodiments, the suction tube lumen 112 may providerinsing fluids from the suction tube 108 e.

The inflation tube lumen 114 is an extension of the inflation tube 110that extends along the length of the catheter 106. The inflation tubelumen 114 may be connected to the inflation tube 110. The inflation tubelumen 114 may also be an extension of the inflation tube 110 thatextends along the length and inside the wall of the catheter 106. Inanother embodiment, the inflation tube lumen 114 may attach to theexterior surface of the catheter 106 and extend along the length of thecatheter 106.

The suction lumen exit point 116 is the point where the suction lumen114 emerges from the catheter 106. The suction lumen exit point 116 isstrategically located along the length of the catheter 106 so that it isproximal to the location where secretion accumulates in the regionbordering the cuff and trachea above the balloon.

The balloon 118 is an inflatable resilient cuff. The balloon 118 servesas a seal between the tracheal tube and the patient's trachea wall toallow for positive pressure ventilation. Positive pressure ventilationis a mechanical ventilation in which air is delivered into the airwaysand lungs under positive pressure, usually via an endotracheal tube,producing positive airway pressure during inspiration. The balloon 118may be made from various compositions of rubber or elastic polymerpolyurethane. The thickness and elasticity of the rubber material mayvary, depending on the intended use of the balloon 118. In anembodiment, the balloon 118 is 5 cm long and 3 cm in diameter. Excludingrare errors in calcium metabolism, most human male and female tracheadiameters fall between 25-29 mm and 23-27 mm, respectively. In anembodiment, the seal between each chamber is not complete so as to allowair to flow from one balloon to the next (the opening between chambersmay be the width of the balloon and between 0.1-0.5 cm high). In someembodiments, the balloon 118 may be a high pressure, low volume balloon.In other embodiments, the balloon 118 may be a low pressure, high volumeballoon. Depending on the intended purpose and use of the balloon, theappropriate material is used. When introduced into the patient, theballoon 118 is initially deflated. Once the tracheal tube system 100 isplaced inside the patient's trachea, the inflation tube 110 may beadapted to a fluid supplying device to inflate the balloon 118. Theballoon 118 is connected to the inflation lumen 114. Once the balloon118 is inflated, the shape and expanded size of the balloon 118 createsa seal against the tracheal wall, thereby preventing gases being pumpedinto the lungs via the catheter 106 from backing up around the tube andescaping through the tracheal tube, thereby providing a positivepressure ventilation. The inflation of the balloon 118 creates a seal toprovide a positive pressure necessary to artificially ventilate thelungs.

The balloon 118 is attached to the catheter 106 between the suctionlumen exit 116 and the distal end 122. The balloon 118 is completelysealed to the catheter 106 at the end of the balloon distal to thesuction lumen exit 116. However, the opposite end of the balloon 118 isnot sealed to the catheter 106. Instead, the balloon 118 proximal to theopen distal end 122 is cylindrical shaped. The balloon, when notattached to a tracheal tube resembles the shape of a bottle without thebottom portion of the bottle. The shape of the balloon is created by theballoons circular chambers and the size of chambers can vary, thelargest balloon is first and the size of the balloons decreases alongthe direction going towards the lungs. For example, in an embodiment,the balloon 118 diameters of the chambers, in order from proximal todistal, are 3 cm, 1 cm, 0.6 cm, 0.4 cm, 0.2 cm, and 0.1 cm,respectively.

In another embodiment, the balloon 118 may extend from the open distalend 122 along the length of catheter 106 and ending proximal to theconnector 102.

Tracheal tubes with balloon 118 may present a problem in that secretionsproduced above the balloon 118 may be prevented from flowing along thechannel of the esophagus or trachea and thereby collect above theballoon 118, providing a site for the possible accumulation ofpathogens. Occasionally, these pathogens may find their way through thecuff created by balloon 118 and end up below the cuff near the opendistal end 122. Once the pathogens make it through the balloon 118, thepathogens may find their way into the patient's lungs and create harmfulinfection. The accumulation of secretion above the balloon 118 maypresent other problems as well.

The suction line 120 is a tube with many small holes distributed allaround the tube and all along the tube length. In an embodiment, thesuction line 120 is 20 cm in length. The small holes allow the suctionand removal of secretion fluid that comes in contact with the suctionline 120. The suction line 120 may be an extension of the suction tube108 e and the suction tube lumen 112. The suction line 120 emerges fromwithin the catheter 106 walls at the suction lumen exit point 116. Theconnection point between the balloon 118 and the catheter 106 proximalto the suction line 120 may be 0.5 cm-1.5 cm above the balloon 118 toensure a secure seal of the balloon 118 to the catheter 106. The suctionline 120 is wrapped around the catheter 106 and above the balloon 118.The suction line 120 wrap provides a 360 degree suction of secretionfluids that collect in the space above the balloon 118 and within thepatient's trachea (area bordered by the cuff and trachea) withoutnegatively impacting ventilation of the patient at the level of the cuffsuction line attached to balloon.

The suction line 120 may also wrap around the balloon 118. The suctionline 120 may wrap around the balloon 118 multiple times beforeterminating at a distal point of the exterior surface of balloon 118.The suction line 120 provides suction of secretions that collect in thespaces between the balloon 118 and the patient's trachea. The suctionline 120 may also provide additional sealing properties between theballoon and the tracheal wall within the patient when there is negativepressure within the suction line 120.

The suction line 120 may also coil around the balloon 118 withinpredefined sleeves on the balloon 118 outer surface. The sleeves will befurther discussed in FIG. 5.

In other embodiments, the suction line 120 may also distribute a rinsingfluid when the suction tube 108 e is adapted to connect to a fluiddispensing device to dispense a rinsing fluid. The rinsing fluid flowsthrough the small holes scattered and is dispersed along the suctionline 120.

The open distal end 122 is the opening at the end of the tracheal tubesystem 100. In most embodiments, the open distal end 122 is the end thatresides inside the patient's tracheal area and the open distal end 122is where the mechanical ventilator's air, traveling through the primarychannel 107 may enter the patient's lungs. When the tracheal tube system100 is intubated inside a patient, the open distal end 122 of thecatheter 106 is situated within the upper respiratory system of thepatient. In current use, the open distal end 122 serves as the primaryair passage way for mechanically ventilating a patient, with an openingin the sidewall of catheter 106 as the secondary source of air passagein the event the open distal end 122 is blocked. In the currentembodiment, the open distal end 122 will still serve as an air passageway.

The enlarged opening 124 provides an alternative air flow source to thepatient's lungs in the event the open distal end 122 is blocked orobstructed. The enlarged opening 124 serves as the primary source of airflow into the patient's lungs since the enlarged opening 124 has anopening considerably larger than the open distal end 122. The airflowfrom enlarged opening 124 comes into contact with the interior layer ofthe balloon 118. The inflated balloon 118 creates a cuff along thetracheal wall to prevent the escape of air pressure between thepatient's lung and the tracheal tube system 100. The airflow that comesout of the enlarged opening 124 may flow around the inner layer of theballoon 118 and get redirected towards the patient's lung. The enlargedopening 124 may have a length that is slightly longer along the lengthof the catheter 106 than the balloon 118 such that the opening 124 maystart from a point proximate to the 360 degree seal of the balloon 118with the catheter 106 proximal to the suction lumen exit 116 and extendbeyond the point where the balloon 118 ends proximal to the distal end122. The width of the enlarged Opening 124 may be adjusted to create alarger cross sectional area of air flow to travel between the patient'slungs and the catheter 106.

In another embodiment, where the length of the balloon 118 may extendfrom proximal to the open distal end 122 along the length of catheter106 and terminate proximal to proximal open end 104, the length of theenlarged opening 124 may extend along the length of the entire catheter106 to provide a larger amount of area for airflow to travel between theprimary channel 107 and the patient's lungs.

The enlarged air passage way 126 is a passage way through which fluidspass between the patient's trachea and the tracheal tube system 100. Theenlarged air passage way 126 may be determined by taking thecross-sectional area measured by the inner diameter of the inflatedballoon 118 and subtracting the cross-sectional area of the catheter106. The enlarged air passage way 126 allows the same amount of airvolume to move into the patient's lungs but at a slower velocity ascompared to prior devices.

The velocity at which a volume of air flows through a pipe may beincreased or decreased based on the diameter of the pipe. Decreasing theinput velocity increases particle size, decreases the aerosolization,and decreases microspeciation. The diameter of the pipe defines thecross-sectional area available for the volume of air to flow through.The velocity of a volume of air flows through a passage way may bereduced if the diameter of the passage way is increased. Likewise, whenthe diameter of the passage way is reduced, to move the same fixedvolume of air through the reduced diameter passage way, the velocity atwhich the volume of air flows must be increased to move the same fixedvolume of air through the reduced diameter passage way. The increaseddiameter of the passage way will increase the cross-sectional area forair to travel through. With a larger cross-sectional area for air totravel through the tracheal tube system 100 based on the enlarged airpassage way 126 created by the shape of the balloon 118 proximal to theopen distal end 122, the same volume of air that needs to flow into thelung(s) at the enlarged air passway 126 may be delivered to the lung(s)at a reduced velocity. The volume of air that flows through from theenlarged opening 124 located within the balloon 118 is delivered to thelungs through the enlarged air passageway 126. The reduction in velocityof airflow at the enlarged air passage way 126 helps to address a commoncause of issues with tracheal procedures, such as Ventillator AssociatedPneumonia (VAP). VAP can be minimized by eliminating the “aerolization”of foreign bodies that shoot into the lower area of the lungs from thehigh speed of the ventilator. Currently, the “aerolization” of foreignbody traveling at high velocity into the lungs is due to the small crosssectional area of the traditional tracheal tube. The smaller the crosssectional area of the tube, the higher the velocity is required to movethe same volume of air. The enlarged air passage way 126 may allow theappropriate amount of air to travel into the patient's lungs at areduced velocity of airflow that in turn may help to reduce VAP. In anembodiment, the length of the air passage way 126 is 4.5 cm, whereas incontrast a standard Murphy's Eye is 1.0 to 1.5 cm.

FIG. 2 shows a diagram similar to that of FIG. 1 but illustratinganother embodiment of a tracheal tube. The tracheal tube system 200 mayinclude the following elements as explained in FIG. 1: at least oneconnector 102, a catheter 106 having opposed open proximal end 104 andopen distal end 122, a suction device 108 a, an air dispensor device 108b, a fluid dispensor device 108 c, a fluid reservoir 108 d, at least onesuction tube 108 e, at least one inflation tube 110 a, a pilot balloon110 b, an inflation fluid supplying device 110 c, at least one balloon118, at least one suction line 120, a plurality of enlarged opening 124,and at least one enlarged air passage way 126. In other embodiments thetracheal tube system 200 may not have all of the elements or featureslisted and/or may have other elements or features instead of or inaddition to those listed.

Furthermore, the tracheal tube system 200 may also include a vocal chordcrease 202. The vocal chord crease 202 is a portion of the balloon 118that is narrow and extends for an amount necessary to clear the vocalchord of the patient. The purpose of the vocal chord crease 202 is tominimize contact between the tracheal tube system 200 and the patient'svocal chord. The balloon 118 in the current embodiment extends alongapproximately the entire length of the catheter 106. Other than thelength of the balloon 118 and the crease in the balloon 118 at the vocalchord crease 202, the balloon 118 is essentially the same as theembodiment described in FIG. 1. No balloons are located in the crease toavoid direct pressure on the vocal chords. The crease is suspended offthe vocal cords by balloons on either end of the crease, and in anembodiment, the crease is color coded so that medical personnel can seewhere to position the crease.

The plurality of the enlarged openings 124 is the primary air flowchannel for the ventilation of the patient. The plurality of theenlarged openings 124 allows the velocity of the airflow between thepatient's lungs and the tracheal tube system 200 to be comparable to thevelocity of the airflow the patient would experience without anartificial ventilation system.

In an embodiment, balloon 118 forms a tube surrounding and attached tocatheter 106, which is open at both ends, so that air may enter one endof the tube formed by balloon 118 and exit the other end of the tubeformed by balloon 118. When one end of endotracheal tube system 200 isplaced within a patient, air may enter the patient via both the tubeformed by balloon 118 and catheter 106, so that air may enter and travelinto the patient through a larger cross sectional area than were balloon118 not present or crossed.

FIG. 3 shows a cross-sectional view 300 of an embodiment of the catheterof FIG. 1 taken longitudinally through the catheter at 3-3. Thecross-sectional view 300 may include an exterior surface 302, aninterior surface 304, a wall thickness 306, a catheter 106, suctionlumen 112, inflation lumen 114, and primary channel 107.

The catheter 106, suction lumen 112, inflation lumen 114, and primarychannel 107 were discussed in FIG. 1. The exterior surface 302 is theexterior surface of catheter 106. The interior surface 304 is theinterior surface of the catheter 106. The wall 306 is the tube thicknessdetermined by the exterior surface 302 and the inner surface 304. Thethickness of the wall 306 may vary based on the different uses andapplication of the tracheal tube system 100.

The suction lumen 112 may be an extension of the suction tube 108 e(from FIG. 1) wherein the suction lumen 112 is configured to run alongthe inside of the wall 306. In another embodiment, the suction lumen 306may be attached to run along the exterior surface 302 of the catheter106.

The inflation lumen 114 may be an extension of the inflation tube 110 a(from FIG. 1) wherein the inflation lumen 114 is configured to run alongthe inside of the wall 306. The inflation lumen 114 may be situatedopposite the suction lumen 112. In another embodiment, the inflationlumen 114 may be configured to run along the exterior surface 302 of thecatheter 106.

FIG. 4 shows a cross-sectional view 400 of an embodiment of a catheter106 and a balloon 118 of FIG. 1 taken longitudinally through thecatheter 106 and the balloon 118 at 4-4. The cross-sectional view 400may include a spinal sealant 402, a balloon inner layer 404, a balloonthickness 406, and a catheter 106. Furthermore, cross-sectional view 400may also include a primary channel 107, a balloon 118, a suction line120, and an enlarged airway passage 126; all of which are furtherdefined in FIG. 1.

The spinal sealant 402 is the contact point along the outer surface ofthe catheter 106 and the inner surface of balloon 118. The balloon innerlayer 404 is the inner layer of the balloon 118. The balloon thickness406 is the thickness of the balloon 118 when fully inflated. The balloonthickness 406 may be a variable in the enlarged airway passage 126. Thethicker the balloon, the smaller the enlarged airway passage. Likewise,the thinner the balloon thickness 406, the larger the enlarged airwaypassage 126. The balloon thickness 406 may vary to provide theappropriate amount of enlarged airway passage 126. The spinal sealant402 is designed to not have any contact with the enlarged opening 124.

The spinal sealant 402 connection point may extend the length of thecatheter 106 (which is situated inside the balloon 118) to create asecure attachment between the balloon 118 and the catheter 106. In anembodiment, the spinal sealant 402 may be located opposite the enlargedopening 124 located on the catheter 106, so that the enlarged opening124 is not in contact with the inner wall of the balloon 118. The spinalsealant 402 may be glued to the inner walls of balloon 118. In anotherembodiment, the spinal sealant 402 may be heat infused by melting theinner wall of the balloon 118 along the spinal sealant 402 together. Theairflow that comes out of the enlarged Murphy's Eye will travel throughthe catheter 106 by way of the primary channel 107 and exit the catheter106 in one of two locations: 1) at the open distal end 122 or 2) at theenlarged opening 124. The air exiting the enlarged opening 124eventually flows through the enlarged air passage way 126.

FIG. 5 shows an embodiment of the balloon assembly 500. The balloonassembly 500 may include an outer balloon sheet 502, a plurality ofsleeves 504, an inner balloon sheet 506, a tube connection point 508, adistal edge 510, and an inflation connection point 512.

The outer balloon sheet 502 is the exterior layer of the balloon 118that comes into contact with the patient's tracheal walls. The outerballoon sheet 502 is generally a rubber material with various thicknessand elasticity, depending on the application of the balloon. Forexample, the balloon 118 may be adapted to be used in as a low volume,high pressure cuff or a high volume, low pressure cuff. In a low volume,high pressure application, the material of the balloon may be slightlythicker and less elastic whereas in a high volume, low pressureapplication, the material may be thinner and more elastic.

The plurality of sleeves 504 are like channels arranged parallel to oneanother in a diagonal configuration with respect to the outer balloonsheet 502. The sleeves 504 are aligned diagonally in such a way thatwhen the outer balloon sheet 502 is curled into a cylindrical shape, thesleeves 504 line up at the connection point to create a a single helicalgroove around the cylindrical shape of the outer balloon sheet. Once thesleeves 504 are aligned, the sleeves may allow the suction line 120 towrap around the balloon 118 in an organized and predictable form becausethe suction line 120 fits neatly into the sleeves. Once the suction linewrap 120 is wrapped around the balloon 118 within the sleeves 504, thesuction line wrap 120 may provide a slight protrusion over the balloonsurface. The protrusion provides a more secure and stable seal betweenthe balloon 118 and the patient's tracheal wall because the suctioneffect created by the suction line wrap 120 around the balloon 118 helpsto securely seal the balloon with the tracheal walls.

The inner balloon sheet 506 is the inner layer of the balloon 118. Theinner balloon sheet 506 when attached to the outer balloon sheet 502allows the balloon 118 to take form. The tube connection point 508 isthe portion of the balloon 118 that attaches the balloon 118 to thetracheal tube. The tube connection point 508 is the only portion of theballoon 118 that attaches to the tracheal tube. The attachment is a 360degree tight seal around the tube. When the outer balloon sheet 502 andinner balloon sheet 506 are attached, the tube connection point 508 issealed tight to not allow any air to travel in between the two sheetbecause the purpose of the connection point 508 is attach the balloon118 to the tracheal tube.

The distal edge 510 is the edge of the outer balloon sheet 502 and innerballoon sheet 506 that is opposite the tube connection point 508. Thedistal edge 510 is the section of the outer and inner balloon sheetsthat is sealed together to create a balloon shape.

The longitudinal edge 512 is the edge that runs along the balloonlongitudinally. One end of the edge is the distal edge 510 and the otherend of the edge is the connection point 508. The longitudinal edge 512of the inner balloon sheet 506 will be the edge that seals to theopposing longitudinal edge 512 of the inner balloon sheet 506 to createa cylindrical shape for the inner balloon sheet 506. Likewise, thelongitudinal edge 512 of the outer balloon sheet 502 will be the edgethat seals the opposing longitudinal edge 512 of the outer balloon sheetto create a cylindrical shape for the outer balloon sheet 502. The outerballoon sheet 502 is slightly larger than the inner balloon sheet 506 sothat the cylindrical shape of the outer sheet may fit on the outside ofthe cylindrical shape of the inner sheet. The sleeves 504 are outwardfacing on the outside of the outer balloon sheet's cylindrical form.

The inflation connection point 512 is where the balloon's inflationfluid enters and exists to inflate and deflate the balloon 118respectively. The inflation connection point 512 connects to theinflation lumen 114 (FIG. 1). The inflation connection point 512 may bea hole or it may be an actual small valve connector to connect to theinflation lumen 114. In other embodiments, it may just be a marking onthe inner balloon sheet to provide guidance to create a hole uponassembly and attachment of the balloon 118 to the catheter 106.

The sleeves 504 on the balloon 118 will create a channel to allow thesuction line wrap 114 to remain securely attached to the balloon 118.Once the balloon 118 is inflated, the suction line wrap 114 fitssecurely in the helical groove 504 (FIG. 5) on the balloon 118. Thesuction line wrap 114 provides a slight protrusion over the balloonsurface to provide a more secure and stable seal of the balloon and thetracheal tube system 100 within the patient because the slightprotrusion is that of the suction line wrap 114. The suction effectcreated by the suction line wrap 114 around the balloon 118 helps tosecurely seal the balloon with the tracheal walls

The balloon 118 is shaped by fusing the two layers of the balloon sheetstogether where the outer balloon sheet 502 will have a sleeve 504 toallow the suction line 120 to lay within. One end of the balloon 118 iscompletely sealed to the catheter 106 proximal to suction line 120. Theother distal end of the balloon will not be completely sealed to thecatheter 106. Instead, the inner balloon layer 506 will be attached tothe spine portion of the catheter 106 as displayed as the spinal sealant402 (FIG. 4).

FIG. 6a shows a flowchart of an embodiment of method 600 a in which acaregiver is intubating a patient. In step 602, the caregiver determinesthat a patient needs an advance airway orally. In step 604, thecaregiver opens the patient's mouth to begin the intubation process. Instep 606, the caregiver pushes the patient's jaw forward to create anadequate opening to perform the intubation.

In step 608, the caregiver may use a laryngoscope as a guide to placethe endotracheal tube above the epiglottis. The caregiver may also use aglidescope to assist with the intubation process. In some situations,where no guiding tools are available, the caregiver may intubate blindlyif the situation requires immediate intubation. A laryngoscope is amedical device that is used to obtain a view of the vocal folds and theglottis. Laryngoscopy (larynx+scopy) may be performed to facilitatetracheal intubation. A glidescope is the first commercially availablevideo laryngoscope. The glidescope incorporates a high resolutiondigital camera, connected by a video cable to a high resolution LCDmonitor. It may be used for tracheal intubation to provide controlledmechanical ventilation. When using the laryngoscope or glidescope tofaciliate intubation, the caregiver should exercise special care toidentify the vocal chords in order to properly intubate the trachealtube to prevent contact between the balloon 118 and the vocal chords. Ifthe caregiver does not properly intubate the tracheal tube below thevocal chord and if upon inflation of the balloon 118 the cuff expandsonto the vocal chord, it may damage the patient's vocal chord. Extracare must be exercised to ensure the intubation is performed correctlyand the vocal chords are clear of contact by the balloon once theballoon 118 is inflated. An aluminum stylet may be used to provide theflexible endotracheal tube with some support and stiffness to assistwith the intubation process.

In step 610, the caregiver places the tracheal tube into place properlywithout causing injury. Injuries may include breaking teeth or damagingvocal chords. In step 612, once the intubation is complete, thecaregiver removes the aluminum stylet from the tracheal tube.

In step 614, the caregiver inflates the balloon with air by attaching asyringe or any other fluid providing device that may be required toinflate the balloon. In some embodiments, air may be the fluid ofchoice. In other embodiments, a liquid based fluid may be used. When theballoon is inflated, the coiled suction line 120 form fits into thesleeves on the outside of the balloon.

In step 615, the caregiver deploys the suction line 120 and the balloonis inflated to the tracheal border.

In step 616, the caregiver connects the suction tube 108 e to a suctiondevice 108 a to provide a constant stream of suction to the regionbordered by the cuff and trachea above the balloon 118. The suctiondevice may have a suction power adjustable knob to set a desiredsuction. By connecting the suction tube 108 e to the suction device 108a, the removal of secretion build up located above the balloon 118 andbetween the tracheal walls and the balloon may continue indefinitelywithout the need for a caregiver to constantly monitor the patient forsecretion build up.

In step 617, the suction line 120 creates a seal between the balloon 118and the trachea.

In an embodiment, each of the steps of method 600 a is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 6a ,steps 604-617 may not be distinct steps. In other embodiments, method600 a may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 600 amay be performed in another order. Subsets of the steps listed above aspart of method 600 a may be used to form their own method.

FIG. 6b shows a flowchart of an embodiment of method 600 b in which acaregiver is removing an endotracheal tube. In step 652, the caregiverdeflates the balloon 118 by pressing the pilot balloon 110 b. In step654, the caregiver carefully removes the endotracheal tube from thepatient orally.

In an embodiment, each of the steps of method 600 b is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 6b ,step 652-654 may not be distinct steps. In other embodiments, method 600b may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 600 bmay be performed in another order. Subsets of the steps listed above aspart of method 600 b may be used to form their own method.

FIG. 7a shows a flowchart of an embodiment of method 700 a in which asuctioning device is suctioning secretion from the region bordered bythe cuff and trachea. In step 702, the suction tube 108 e is connectedto a suction device 108 a. In step 704, the negative pressure within thesuction tube 108 e is transferred through the suction tube lumen 112 tothe suction line 120. In step 706, the negative pressure creates anegative pressure/suction at the suction holes throughout the suctionline 120. In step 708, the accumulated secretions are suctioned throughthe suction holes for disposal. In step 710, the negative pressurewithin the suction line creates a seal between the balloon 118 and thepatient's tracheal wall. The secretions may be collected for samples forculture for diagnosing and monitoring.

In an embodiment, each of the steps of method 700 a is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 7a ,step 702-710 may not be distinct steps. In other embodiments, method 700a may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 700 amay be performed in another order. Subsets of the steps listed above aspart of method 700 a may be used to form their own method.

FIG. 7b shows a flowchart of an embodiment of method 700 b in which arinsing fluid dispensing device is applying a rinsing fluid. In step742, the suction tube 108 e is connected to a rinsing fluid device 108c. In step 744, the rinsing fluid travels through the suction tube 108e, the suction tube lumen 112, and the suction line 120. In step 746,the rinsing fluid is dispersed through the suction holes on the suctionline 120. The rinsing fluid is allowed to momentarily interact with themucous and area bordered by the cuff and trachea. Depending on therinsing fluid used, the mucous may be loosened to allow it to be easilyextracted. In step 748, the suction tube 108 e is reconnected to asuction device 108 a to remove the rinsing fluid and any other secretionthat may have collected during the rinsing fluid administering process.

In an embodiment, each of the steps of method 700 b is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 7b ,step 742-748 may not be distinct steps. In other embodiments, method 700b may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 700 bmay be performed in another order. Subsets of the steps listed above aspart of method 700 b may be used to form their own method.

FIG. 7c shows a flowchart of an embodiment of method 700 c in which amechanical ventilator is artificially ventiliating a patient. In step762, a tracheal tube system 100 is connected to a mechanical ventilatorvia connector 102. In step 764, the mechanical ventilator pumps air toand from the patient's lung(s) by way of a primary channel 107, theenlarged opening 124, and the open distal end 122. The velocity ofoxygen and air flowing into the patient's lungs is reduced as a resultof the enlarged opening 124 and the enlarged air passage way 126.

In an embodiment, each of the steps of method 700 c is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 7c ,step 762-764 may not be distinct steps. In other embodiments, method 700c may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 700 cmay be performed in another order. Subsets of the steps listed above aspart of method 700 c may be used to form their own method.

FIG. 8 shows a flowchart of an embodiment of method 800 in which atracheal tube of system 100 is manufactured. In step 802, a trachealtube is made. In step 804, a balloon 118 is made, which involves thestep of making the balloon 118. In step 806, the balloon 118 is attachedto the tracheal tube from step 802. In other embodiments of method 800,step 804 may be performed before step 802. However, step 806 requiresthat step 802 and step 804 are performed in order to attach the trachealtube and the balloon 118.

In an embodiment, each of the steps of method 800 is a distinct step. Inanother embodiment, although depicted as distinct steps in FIG. 8, step802-806 may not be distinct steps. In other embodiments, method 800 maynot have all of the above steps and/or may have other steps in additionto or instead of those listed above. The steps of method 800 may beperformed in another order. Subsets of the steps listed above as part ofmethod 800 may be used to form their own method.

FIG. 9 shows a flowchart of an embodiment of a method for implementingstep 802 in which a tracheal tube system 100 is manufactured. In step902, a tracheal tube is made, which may include making a catheter 106from a plastic (polyvinyl chloride, PVC) material with 3 lumencomprising a suction lumen 108 e, an inflation lumen 110 a and a primarychannel 107. In other embodiments, other types of material may be usedto make the catheter 106 such as wire-reinforced silicone, siliconerubber, latex rubber, or stainless steel. The length, diameter andthickness of the catheter 106 may vary depending on the size of thecatheter being created for the various ages, genders and sizes of atargeted user base. The suction lumen 108 e and inflation lumen 110 aare built into the wall of the catheter 106. In other embodiments, thesuction lumen 108 e and inflation lumen 110 a may be tubes attached onthe outer surfaces of catheter 106.

In step 904, make a suction lumen exit 116. The suction lumen exit 116is an exit hole at the distal end of the suction lumen 108 e proximal tothe balloon 118. The suction lumen exit 116 may be located slightlyabove the point where the balloon 118 will be attached to the catheter106.

In step 906, a bevel cut is made at open distal end 122. The bevel shapeof the catheter 106 helps with the intubation process of the trachealtube.

In step 908, an enlarged opening 124 is made. Step 908 involves cuttingan elongated oval shaped opening proximal to the open distal end 122 onthe top side of the catheter 106. The length of the enlarged opening 124is extended along the length of the catheter 106 starting proximal tothe open distal end 122 and extending proximal to the suction lumen exithole 116.

In step 910, an inflation tube 110 a, suction tube 108 e, and suctionline 120 is attached to the catheter 106. An inflation tube 110 a isattached to the inflation lumen 114 on one end and to a pilot balloon110 b on the opposite end. In another embodiment, inflation tube 110 amay be an extension of inflation lumen 114 and a part of step 902. Inother embodiments, pilot balloon 110 b may be attached to the inflationtube prior to intubation.

A suction tube 108 e is attached to the suction tube lumen 112. Inanother embodiment, suction tube 108 e may be an extension of suctiontube lumen 112 and a part of step 902.

A suction line 120 is attached to the suction lumen exit 116. Thesuction line 118 may be similar to the suction tube 108 e in material,shape, and diameter. However, the suction line 120 contains many smallholes distributed throughout the suction line 120 in order to providefluid transmission in and out of the suction line 120. In anotherembodiment, the suction line 120 may be an extension of the suctionlumen 112 and a part of the suction lumen exit 116.

In step 912, a preformed balloon cuff is attached to the balloon 118.

In an embodiment, each of the steps of method 802 is a distinct step. Inanother embodiment, although depicted as distinct steps in FIG. 9, step902-912 may not be distinct steps. In other embodiments, method 802 maynot have all of the above steps and/or may have other steps in additionto or instead of those listed above. The steps of method 802 may beperformed in another order. Subsets of the steps listed above as part ofmethod 802 may be used to form their own method.

FIG. 10 shows a flowchart of an embodiment of a method of implementingstep 804 in which a balloon is manufactured. In step 1002, an outerballoon sheet 502 is made using a flexible rubber based thin sheet thatis generally used in balloon manufacturing for endotracheal tubes. Theouter balloon sheet 502 comprises a plurality of sleeves 504 arrangeddiagonally across the sheet to serve as channels for the suction line120 to fit into when the balloon 118 is inflated. The diagonally alignedsleeves on the outer balloon sheet 502, when curled lengthwise andattached, creates a helical groove for the suction line 120. The shapeof the outer sheet is displayed in FIG. 5.

In step 1004, an inner balloon sheet 506 is made using a similarmaterial as the material used in step 1002 when making the outer balloonsheet 502. The inner balloon sheet 506 is the same shape as the outerballoon sheet 502. The inner balloon 506 does not contain sleevesarranged diagonally across the sheet.

In step 1006, the inner balloon sheet 506 is curled into a cylindricalshape and sealed along the longitudinal edge 512. In step 1008, theouter balloon sheet 502 is curled into a cylindrical shape and sealedalong its longitudinal edge 512.

In step 1010, the outer balloon sheet 502 and inner balloon sheet 506are sealed to one another along the distal edge 510 and the balloonconnection point 508. The outer balloon sheet 502 is on the outside ofthe connection with the sleeves 504 facing outwards. The balloonconnection point 508 is sealed completely to ensure there will be nospaces for air to inflate in connection point 508 area of the balloonassembly.

In an embodiment, each of the steps of method 804 is a distinct step. Inanother embodiment, although depicted as distinct steps in FIG. 10, step1002-1010 may not be distinct steps. In other embodiments, method 804may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 804may be performed in another order. Subsets of the steps listed above aspart of method 804 may be used to form their own method.

FIG. 11 shows a flowchart of an embodiment of a method for implementingstep 806 in which a balloon is attached to a tracheal tube. Theattachment of the balloon 118 assembled from step 804 and tracheal tubeassembled from step 802. In step 1102, the balloon 118 is attached tothe tracheal tube assembled from step 802 by inserting the distal end122 through the balloon 118 from the connection point 508 towards thedistal edge 510. The connection point 508 is sealed completely aroundthe catheter 106 proximal to the suction lumen exit 116 without cominginto contact with the suction lumen exit 116.

In step 1104, the inner surface of the balloon 118 is sealed to thespinal length of the catheter 106 along the spinal seal 402. The spinalseal 402 does not contact or obstruct the enlarged opening 124. Theinflation lumen 114 is connected to the balloon 118 at the inflationconnection point 512. In step 1106, the suction line 120 is coiledaround the catheter 106 from the suction lumen exit 116 towards thedistal end 122. The suction line 120 is further coiled around thedeflated balloon 118 guided by the helical groove created by the sleeves504.

In step 1108, the suction line 120 is attached to the outer surface ofthe distal end of balloon 118. The attached point may be proximal alongthe distal edge 510 of the balloon, without actually coming into contactwith the sealed distal edge 510.

In an embodiment, each of the steps of method 806 is a distinct step. Inanother embodiment, although depicted as distinct steps in FIG. 11, step1102-1108 may not be distinct steps. In other embodiments, method 806may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 806may be performed in another order. Subsets of the steps listed above aspart of method 806 may be used to form their own method.

ALTERNATIVES AND EXTENSIONS

Each embodiment disclosed herein may be used or otherwise combined withany of the other embodiments disclosed. Any element of any embodimentmay be used in any embodiment.

Although the invention has been described with reference to specificembodiments, it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted forelements thereof without departing from the true spirit and scope of theinvention. In addition, modifications may be made without departing fromthe essential teachings of the invention.

The invention claimed is:
 1. A tracheal tube system comprising: a firsttube that is flexible and hollow allowing air to pass through, the firsttube having sidewalls forming the first tube, an outer diameter formedby an outer surface of the first tube sidewalls, a first end that isopen and allows air to flow in and out of the first tube, and a secondend that is open and allows air to flow in and out of the first tube; athird opening positioned on the sidewalls between the first end and thesecond end, which allows air to enter and exit; a balloon attached tothe first tube; the balloon having a first wall with an outer surfacefacing the first tube and a second wall with an outer wall facing awayfrom the first tube; the balloon having a shape and size such that wheninflated, the balloon forms a second tube surrounding the first tubewith an air space between the first wall of the balloon and thesidewalls of the first tube, the balloon extending from a first point onthe first tube towards the second end of the first tube and at leastpartially covering the third opening, the first point on the first tubebeing located between the first end of the first tube and the thirdopening, the air space between the balloon and the first tube having afirst end and a second end, the second end of the air space being closerto the second end of the first tube than the first end of the airspace;the second end of the airspace and being open, allowing air to enter andleave the airspace; and a third tube wrapped around the outer wall ofthe balloon, the third tube having a multiplicity of holes alongsidewalls of the third tube adapted such that when inserted into atrachea, negative pressure in the third tube creates suction holding theouter wall of the balloon to walls of the trachea, wherein the outerwall of the balloon is shaped to have a channel included therein wheninflated and the third tube is attached to the balloon within thechannel; wherein when the first tube is adapted to be placed in apatient with the second end of the first tube inside the patient and thefirst end of the first tube outside of the patient, a first portion ofair flowing into the first end of the first tube exits, via the thirdopening in the first tube into the airspace between the first tube andthe balloon, out of the second end of the airspace, in addition to asecond portion of the air entering the first end of the first tubeexiting out of the second end of the first tube.
 2. The tracheal tubesystem of claim 1, wherein the first tube has a length, the balloonbeing attached along a line on the outer surface of the first tube andthe first wall of the balloon, the line extending along the length ofthe first tube.
 3. The tracheal tube system of claim 1, wherein theballoon is coupled to an inflation tube at an orifice opening into theballoon and air pumped into the inflation tube enters the orificeopening between the first wall of the balloon and the second wall of theballoon to inflate the balloon.
 4. The tracheal tube system of claim 1,wherein the first tube has a lumen and the third tube is coupled to thelumen so that negative pressure in the lumen causes negative pressure inthe third tube, thereby creating the suction.
 5. The tracheal tubesystem of claim 4, wherein the lumen has a first opening attached to thethird tube and a second opening attached to a fourth tube.
 6. Thetracheal tube system of claim 5, wherein the balloon is coupled to aninflation tube at an orifice opening into the balloon so that air pumpedinto the inflation tube enters the orifice opening and accumulatesbetween the first wall of the balloon and the second wall of the balloonso as to inflate the balloon.
 7. The tracheal tube system of claim 6,wherein the first tube has a second lumen and a first end of the secondlumen is coupled to an inflation tube and the balloon is coupled to thesecond end of the second lumen.
 8. A tracheal tube system comprising: afirst tube that is flexible and hollow; the first tube having a firstend that is open and a second end that is open, therein allowing air toflow into the first end through the tube out the second end; a balloonattached to the first end of the first tube and the second end of thefirst tube and surrounding a portion of the first tube, the balloonforming a second flexible tube surrounding the portion of the first tubewhen inflated; a flexible third tube wrapped around an outer surface ofan outer wall of the balloon adapted such that when the tracheal tubesystem is in a trachea, the third tube is located between the balloonand a wall of the trachea, the third tube having a multiplicity of holesalong sidewalls of the third tube, adapted such that when inserted intothe trachea, negative pressure in the third tube creates suction holdingan outer wall of the balloon to walls of the trachea, wherein the outerwall of the balloon is shaped to have a channel included therein wheninflated and the third tube is attached to the balloon within thechannel.